跳至主要内容
临床试验/NCT02135991
NCT02135991已完成不适用

Preparing to Run Effective Prevention

RAND15 个研究点 分布在 1 个国家目标入组 990 人开始时间: 2013年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
RAND
入组人数
990
试验地点
15
主要终点
Drug use

研究概览

简要总结

Young people can engage in a variety of negative behaviors-such as drug use, underage drinking, and premarital sex-that exact a high toll on local communities. These activities are often the target of community-based prevention efforts. Getting To Outcomes (GTO) is an approach that includes a toolkit, technical assistance, and training, organized around a 10-step process, that helps communities plan, implement, and evaluate the impact of their programs that attempt to prevent these negative behaviors. This study will examine the degree to which Getting To Outcomes helps Boys and Girls Clubs implement an evidence based drug prevention program.

详细描述

As a nation, the U.S. invests heavily in community-based organizations to conduct interventions, proven through research, to reduce the high rates of alcohol and drug use among teens. Much less is invested in helping communities implement these programs with quality. Although many evidence-based programs exist to address alcohol and drug use, communities face difficulty implementing them and achieving the same outcomes as researchers. This "gap" is because resources are limited, prevention is complex, and communities often lack the capacity-or the knowledge, attitudes, and skills-needed to implement "off the shelf" programs well. Common ways to bridge this gap, such as information dissemination, fail to change practice or outcomes at the local level in part because it does not sufficiently address capacity of community practitioners. Therefore, building a community's capacity is a method that could improve the quality of implementation and outcomes. Getting To Outcomes (GTO) is an implementation support intervention shown to improve the capacity of practitioners to conduct evidence-based programs, but its impact on fidelity and youth outcomes has not been studied. The study-Preparing to Run Effective Prevention (PREP)-will be a cluster randomized controlled trial using primary data from middle school youth (990) and program staff from 33 cooperating Boys and Girls Clubs sites (Sites) to assess how GTO impacts the fidelity, outcomes, and costs of an evidence-based program to prevent alcohol and drug use (Project CHOICE, PC). All 33 sites will receive training in PC. 16 Sites will conduct PC in a way typical of community-based organizations (PC only); 17 Sites will conduct PC augmented by GTO, comprised of training, onsite technical assistance, and a written GTO manual. The study will: (1) Assess the use of GTO and compare Sites' capacity between PC+GTO and PC only; (2) Compare PC fidelity between PC+GTO and PC only groups; (3) Compare alcohol and marijuana outcomes of middle-school youth in the PC+GTO (n=510) and PC only (n=480) groups; and (4) Assess the cost-effectiveness of GTO' impact. To address these aims we will collect data on the delivery and utilization of GTO (e.g., method of delivery, duration, topics); staff capacity to implement research-based interventions; observations of program delivery (fidelity monitoring); youth participants' use of, and attitudes towards, alcohol and marijuana via a survey at baseline and 3 and 6 months follow-up; and costs of both PC alone and PC+GTO. Analyses will examine differences between intervention (PC+GTO) and control (PC only) Sites' capacity, PC fidelity, outcomes, and costs over time, accounting for clustering within site. The PREP study could expand implementation research and serve as a model for how the government and other agencies support strong implementation of evidence-based programs in a wide array of domains. These outcomes are important to providing opportunities for youth to become healthy and productive adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
10 Years 至 14 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Youth participants
  • •Inclusion Criteria:
  • •Age 10-14 and attends a participating boys and girls club

排除标准

  • •Younger than 10, older than 14, does not attend a participating boys and girls club

研究组 & 干预措施

Project CHOICE + Getting To Outcomes

Experimental

Boys and Girls Club sites will receive a) training and materials for Project CHOICE and b) training, ongoing technical assistance for two years, and materials for Getting To Outcomes

干预措施: Getting To Outcomes (Behavioral)

Project CHOICE + Getting To Outcomes

Experimental

Boys and Girls Club sites will receive a) training and materials for Project CHOICE and b) training, ongoing technical assistance for two years, and materials for Getting To Outcomes

干预措施: Project CHOICE (Behavioral)

Project CHOICE only

Active Comparator

Boys and Girls Club sites will receive a) training and materials for Project CHOICE

干预措施: Project CHOICE (Behavioral)

结局指标

主要结局

Drug use

时间窗: Baseline, 3 months, 6 months

initiation and past month prevalence of alcohol use, marijuana use, perceptions of their friends' use of alcohol and marijuana, and resistance self-efficacy

次要结局

  • Fidelity(Each site will implement the 5 sessions of Project Choice twice (one time a year, for two years). In each year, we will collect fidelity data on two of the five sessions, for a total of 4 sessions rated over the two year period, for each site.)
  • Capacity(Annually for the first four years)

研究者

发起方
RAND
申办方类型
Other
责任方
Sponsor

研究点 (15)

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